Anesthesia, TIVA, Balanced Anesthesia, NK Cell

NCT ID: NCT05951842

Last Updated: 2023-07-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-16
• Study Completion Date: 2020-02-28

Brief Summary

Anesthetic method was reported to have an impact on postoperative long-term outcome in cancer patients. In this study, we will investigate the effect of different anesthetic methods on NK cell activity, cytokine response and postoperative outcome in colorectal cancer patients undergoing CRS and HIPEC. We will compare propofol-based total intravenous anesthesia (TIVA) with balanced anesthesia to determine the effect of propofol, inhalation agent, and opioid on tumor genesis, recurrence, NK cell activity, cytokine response, and postoperative outcome.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

TIVA group

In TIVA group, anesthesia will be maintained by propofol and remifentanil infusion under target controlled infusion.

Other names: fresofol MCT 1% inj®; Fresenius kabi, Seoul, Korea, Ultian inj®; Hanlim, Seoul, Korea

Group Type: ACTIVE_COMPARATOR

anesthetic method

Intervention Type: DRUG

Patients will be assigned to one of the groups, TIVA group or Balanced anesthesia group. In TIVA group, anesthesia will be maintained by propofol and remifentanil infusion under target controlled infusion. In contrast, anesthesia will be maintained by sevoflurane and remifentanil infusion in the balanced anesthesia group.

Balanced anesthesia group.

Anesthesia will be maintained by sevoflurane and remifentanil infusion in the balanced anesthesia group.

Other names: Sojourn®, Kyongbo, Seoul, Korea, Ultian inj®; Hanlim, Seoul, Korea,

Group Type: EXPERIMENTAL

anesthetic method

Intervention Type: DRUG

Patients will be assigned to one of the groups, TIVA group or Balanced anesthesia group. In TIVA group, anesthesia will be maintained by propofol and remifentanil infusion under target controlled infusion. In contrast, anesthesia will be maintained by sevoflurane and remifentanil infusion in the balanced anesthesia group.

Interventions

anesthetic method

Patients will be assigned to one of the groups, TIVA group or Balanced anesthesia group. In TIVA group, anesthesia will be maintained by propofol and remifentanil infusion under target controlled infusion. In contrast, anesthesia will be maintained by sevoflurane and remifentanil infusion in the balanced anesthesia group.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Colorectal cancer patients undergoing elective cytoreductive surgery and HIPEC (20-70 yrs old)

2. American Society of Anesthesiologists physical status I, II, III

Exclusion Criteria

1. Patients under 20 years old.

2. Patients with long-term steroid therapy or immunosuppressive therapy.

3. Patients with long-term NSAIDs therapy.

4. Patients who cannot communicate with other person or with cognitive disorder.

5. Patients who cannot read the consent form.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gangnam Severance Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dong Woo Han

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

3-2017-0378

Identifier Type: -

Identifier Source: org_study_id